dose finding safety study of val201 in cancer patients

Conditions: Stage III Prostate Carcinoma; Stage IV Prostate Carcinoma

Summary: dose finding safety study of val201 in cancer patients.

a phase i/ii, dose escalation study to assess the safety and tolerability of val201 in patients with locally advanced or metastatic prostate cancer and other advanced solid tumours.

Eligibility criteria:
the study will enrol patients with locally advanced or metastatic prostate cancer. the mtd/mad may also be evaluated in patients with other advanced tumour types for whom no standard effective therapy is available and a rationale for use of val201 exists. the average timeframe is 18-26 weeks per subject and the outcome measured is a composite average for each group. * inclusion criteria: * specific inclusion criteria for patients with prostate cancer * patients with incurable, locally advanced or metastatic prostate cancer where a policy of intermittent hormone therapy has been decided. who have specific clinical parameters. * specific inclusion criteria for patients with other advanced solid tumours * patients with histologically and/or cytologically confirmed advanced solid tumour for whom no standard effective therapy is available and a rationale for use of val201 exists. * patients with incurable, locally advanced or metastatic prostate cancer where a policy of intermittent hormone therapy has been decided. these patients must also have the following: 1. rising psa on three samples (once non-castrate levels established); each over 2 weeks apart, with the last two values being greater than 2 ng/ml. higher than and at least 25% over the nadir. 2. absent or very mild prostate cancer-related symptoms. 3. no plans for any therapy for prostate cancer in the next two months. * general inclusion criteria for all patients * adult patients defined by age greater than 18 years at time of consent. * ability to give written, informed consent prior to any study-specific screening procedures, with the understanding that the consent may be withdrawn by the patient at any time without prejudice. * patient is capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document. * evaluable disease, either measurable on imaging, or with informative tumour marker(s) and a set of specific biochemical and haematological parameters relating to the specific cancer. * negative human chorionic gonadotropin (hcg) test in women of childbearing potential. * sexually active male and female patients of childbearing potential must agree to use an effective method of birth control. female patients may be surgically sterile. * laboratory values at screening: * absolute neutrophil count ≥1.5 x 109/l. * platelets ≥100 x 109/l. * haemoglobin ≥9 g/dl without blood transfusion or colony stimulating factor support. * total bilirubin \<1.5 times the upper limit of normal (uln); * ast (sgot) ≤2.5 times the uln; * alt (sgpt) ≤2.5 times the uln; ≤5 x uln for patients with advanced solid tumours with liver metastases. * serum creatinine ≤1.5 x uln or estimated glomerular filtration rate (gfr) of \>50 ml/min based on the cockcroft-gault formula. * exclusion criteria * specific exclusion criteria for patients with prostate cancer patients has received an anticancer therapy, including investigational agents, within the precious 6 weeks or 4 weeks. * any patients who have undergone prior orchidectomy. * specific exclusion criteria for patients with other advanced solid tumours pregnant or lactating female patients. * documented, symptomatic or uncontrolled brain metastases. * history of clinically significant cardiac condition, including ischemic cardiac event, myocardial infarction or unstable cardiac disease within 3 months previous to the indication of home therapy. * known human immunodeficiency virus positivity. * active hepatitis b or c or other active liver disease (other than malignancy). * any active, clinically significant, viral, bacterial, or systemic fungal infection within previous 4 weeks prior to home therapy. * any medical history that would jeopardize compliance.